TEMPER-EVIDENT LUER LOCK TIP CAP H93864110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-26 for TEMPER-EVIDENT LUER LOCK TIP CAP H93864110 manufactured by Baxter Healthcare - Round Lake.

Event Text Entries

[145114253] A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[145114254] This report summarizes 1 malfunction events. It was reported that a temper-evident luer lock tip cap failed a sterility test for s bacillus kyonggiensis bacteria. This event occurred before use of the device. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-02347
• MDR Report Key: 8558126
• Date Received: 2019-04-26
• Date of Report: 2019-04-26
• Date Mfgr Received: 2019-03-31
• Date Added to Maude: 2019-04-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal: 60073
• Manufacturer Phone: 2242702068
• Manufacturer G1: BAXTER HEALTHCARE - ROUND LAKE
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 22444
• Manufacturer Country: US
• Manufacturer Postal Code: 22444
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TEMPER-EVIDENT LUER LOCK TIP CAP
• Generic Name: DISPENSER, LIQUID MEDICATION
• Product Code: KYX
• Date Received: 2019-04-26
• Model Number: NA
• Catalog Number: H93864110
• Lot Number: 20965
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE - ROUND LAKE
• Manufacturer Address: ROUND LAKE IL

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-26